Skin and nail disorders affect all population at different stages of our life with increased level of incidence in the aging population. Many of such skin disorders are caused by a wide variety of different pathogens that reside on the skin and nails as well as in the deeper skin tissue. Such skin pathogens may include fungi, mold, parasites, bacteria, viruses and other microorganisms. There are different treatments, methods and techniques used to destroy or suppress such pathogens however mostly such treatments would affect one or few of such pathogens without affecting others or the treatment is only applied to a certain part of the foot for example like nails affected by onychomycosis leaving other foot skin untreated. However pathogens residing in other areas of foot skin often cause decease in other foot areas like mold or fungus on the foot skin can easy migrate to the nails. Therefore there is a strong need for a method and device that could integrate multiple treatments of foot skin and nails into a one complex treatment which will result in increased clinical efficacy and outcome for patients as well as it will provide for cost saving for the healthcare system overall.
It is estimated that up to 35 million Americans have onychomycosis, a condition relating to fungal infections of the toenails or fingernails. Onychomycosis is often caused by yeast, dermatophytes, or other molds, and represents approximately 50% of all nail disorders. Toenail infection accounts for approximately 80% of onychomycosis incidence, while fingernails are affected in about 20% of the cases. Dermatophytes are the most frequent cause of nail plate invasion, particularly in toenail onychomycosis. Discoloration, onycholysis, and accumulation of subungual debris and nail plate dystrophy characterize the disease. The disease adversely affects the quality of life of its victims, with subject complaints ranging from unsightly nails and discomfort with footwear, to more serious complications including secondary bacterial infections.
Many methods are known for the treatment of fungal infections, including use of oral and topical drugs. However, onychomycosis has proven to be resistant to most treatments. Nail fungal infections reside in an area difficult to access by conventional topical treatment and anti-fungal drugs cannot readily penetrate the nail plate to reach the infection sites under the nail as well into the nail matrix where infection is often resided therefore clinical efficacy of topical medications is low (20-25% estimated). Also onychomycosis has traditionally been treated by oral administration of anti-fungal drugs. However, the clinical efficacy of the treatment is still not complete (50-60% estimated) and there is a high rate of fungal infection recurrence and with multiple treatment courses patients developed resistant to the oral medication which further reduce the clinical efficacy. There is also known potential for serious side effects of such drugs. Recently significant interest has developed in the use of light irradiation by laser to destroy fungal material through superheating (coagulation) of soft tissue affected with fungus. Exposure of fungi to high temperatures inhibits their growth as well as cause their cell damage and death. This type of therapy using proper light parameters such as wavelength and pulse duration and high level of energy has shown a high clinical efficacy in fungal infection destruction. Light sources capable of emitting high energy in the infrared spectrum proved to be most efficient in eradicating of onychomycosys because high energy infrared radiation with optimum parameters can penetrate deep into skin tissue through the nail plate and into the nail bed as well as deep into the nail matrix coagulating fungal material often residing in these deep skin area. It also has the added benefit of avoiding side effects of oral drugs mentioned above and other systemic concerns for the patient. However delivering of high energy levels to the pathogen affected skin tissue may require efficient cooling mechanisms to remove heat build up in the skin tissue to prevent unwanted collateral damage and provide for a more comfortable treatment for a patient.
Thus, it has been a long felt and unsolved need for an apparatus and method for treatment of fungal infection disease of the lower and upper limbs, including, but not limited to toenails and fingernails that could integrate multiple treatments available now into a one complex treatment and which can be efficiently provided without threat of side effects.
In addition to nails fungal east and bacterial infection, including athlete's foot, mold, viruses, parasites, or other organisms or microorganisms can reside on the skin surface of lower and upper limbs causing chronic infections, which may result in development of wounds including chronic wounds. Some other serious skin disorders like psoriasis and others are common for the skin surface of lower and upper limbs as well. Therefore it is preferable that such method and apparatus will allow to treat in one treatment all or most of foot and hand skin deceases including but not limited to the nails fungal and bacterial infection not only on and under the nails but also on all areas of skin of the lower and upper limbs as well is that it can be used for treatment of wounds, psoriasis and other skin disorders.